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NCT01644188 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 720
- Enrollment target
NCT01644188 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 720 participants.
The verdict
NCT01644188, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 720 participants
- Enrollment target
Study Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points * To evaluate the effect of alirocumab on other lipid parameters * To evaluate the safety and tolerability of alirocumab
Interventions
- DRUG Ezetimibe
- DRUG Alirocumab
- DRUG Placebo (for alirocumab)
- DRUG Placebo (for ezetimibe)
- DRUG Lipid Modifying Therapy (LMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01644188
The ClinicalTrials.gov registry entry for NCT01644188 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ezetimibe is the first listed.
NCT01644188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01644188 about?
NCT01644188 is a clinical study titled "Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)". Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tole...
What is the current status of trial NCT01644188?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 720 participants. The study started on 2012-08. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01644188?
The interventions under investigation include: Ezetimibe (DRUG), Alirocumab (DRUG), Placebo (for alirocumab) (DRUG), Placebo (for ezetimibe) (DRUG), Lipid Modifying Therapy (LMT) (DRUG).
Who is sponsoring clinical trial NCT01644188?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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